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Clinical Trials/NCT04153695
NCT04153695
Unknown
Not Applicable

Therapeutic Flamenco Musical Intervention in Pregnant Women

Telethusa Centre for Flamenco Research1 site in 1 country50 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Telethusa Centre for Flamenco Research
Enrollment
50
Locations
1
Primary Endpoint
Perceived Stress Scale
Last Updated
6 years ago

Overview

Brief Summary

The use of music as a therapy for the psychological and emotional improvement of pregnant women has been well studied. Our hypothesis is that flamenco music can also involve psycho-emotional improvements in pregnant women

Detailed Description

The objective of the study is to analyze the effects of a flamenco musical intervention on the stress and anxiety of pregnant women in five Management Units of the Sanitary District in Bahía de Cádiz-La Janda (Spain). 50 pregnant women will voluntarily participate in this study (25 in a control group and 25 in the experimental group) The psychological health assessment will be measured through the Perceived Stress Scale (PSS), the State-Trait Anxiety Inventory (S-STAI) and the Edinburgh Postnatal Depression Scale (EDPS) pre and post exposure.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 25, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Telethusa Centre for Flamenco Research
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Volunteer
  • Single pregnancy
  • Uncomplicated pregnancy,
  • Expectations of vaginal delivery without complications
  • Gestational age between 18 and 33 weeks,

Exclusion Criteria

  • Visual disorders
  • Hearing disorcers
  • Mental or cognitive disorders
  • Difficulties in pregnancy,
  • Medical complications,
  • Smoker during the gestation period

Outcomes

Primary Outcomes

Perceived Stress Scale

Time Frame: 4 months

Perceived Stress Scale is used in order to measure anxiety in adults. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety". It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month. It consists of fourteen questions that refer to the feelings and thoughts of the person surveyed during the last month. The answer format of each question is a Likert scale with five possible options. The minimum value is 0 (never) and maximun is 4 (very often). Higher score means the worse outcome.

State-Trait Anxiety Inventory

Time Frame: 4 months

It is a psychological inventory based on a 4-point Likert scale (from 0 or "Almost Never" to 3 or "Almost Always") and it consists of 20 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety, so the worse outcome.

Edinburgh Postnatal Depression Scale

Time Frame: 4 Months

The Edinburgh Postnatal Depression Scale is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. This is not intended to provide a diagnosis - only trained health professionals should do this. Each question has four items and is evaluated from 0 to 3, according to the increase in the severity of the symptom. Questions 3, 5, 6, 7, 8, 9, 10 rank in reverse order. The total score can range from 0 to 30, with 0 being the best result and 30 the worst.

Study Sites (1)

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